NCT03782402

Cannabinoids for Taxane Induced Peripheral Neuropathy

The Effect of Dispensed Cannabis on Taxane Induced Peripheral Neuropathy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: Female
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Taxane-induced peripheral neuropathy (TIPN) affects a significant number of women undergoing breast cancer treatment. Some patients may need to shorten their course of treatment, and do not receive the full benefit of chemotherapy as a result. Rodent studies have shown that the cannabinoids may significantly improve hyperalgesia and allodynia induced by paclitaxel. The goal of this study is to investigate the cannabinoids THC and CBD for TIPN.

Detailed description

The investigators' goal is to study the efficacy of cannabinoids as a potential treatment for TIPN. Volunteers with a diagnosis of breast cancer and chemotherapy-induced peripheral neuropathy, secondary to treatment with paclitaxel or docetaxel, will be enrolled. This study involves the administration of cannabinoids in different strength capsules. The primary outcome measures include measures of pain and functional impairment (non-painful symptoms). The scales will include: 1) Brief Pain Inventory-Short Form (BPI) for pain severity ; and 2) BPI pain interference subscale for functional impairment. The study outcomes will also include secondary measures of perception, which will be performed in the laboratory.

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	Cannabinoids	Cannabinoids with THC and CBD versus placebo cannabinoids

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2018-12-20
• Last updated: 2023-01-26
• Results posted: 2023-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study